Long Term Efficacy and Safety of Eryfotona AK-NMSC® in Patients With Actinic Keratosis

A Randomised Double-blind Parallel-group Study to Evaluate the Long-term Effects of Eryfotona AK-NMSC® Cream in the Treatment of Cancerization Field in Patients With Actinic Keratosis.

The purpose of this study is to assess the efficacy, safety and tolerability of Eryfotona AK-NMSC® topical application vs Sunscreen on cancerization field of actinic keratosis patients after 6 months of treatment.

Study Overview

• Status: Unknown
• Conditions: Actinic Keratosis
• Intervention / Treatment: Device: Eryfotona AK-NMSC® cream; Other: Sunscreen SPF 50+

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Reggio Emilia, Italy
    • Dermatology Unit, Medical Department Arcispedale Santa Maria Nuova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Current diagnosis of AK, with ≥4 lesions located in the same anatomical district (within a contiguous 50 cm2 area on the face, bold scalp or forehead);
2. Female or male >18 years of age;
3. Skin type I or II according to Fitzpatrick;
4. Patient has confirmed his/her willingness to participate in this study;.

Exclusion Criteria:

1. Topical drug therapy for AK within the past 3 months or for photoaging in the last 6 months, or had lesion-directed therapy within 2 cm2 of the selected AK area during the previous month;
2. Suitable for surgical, photodynamic or any other topical treatment in the next 6 months;
3. Subjects who suffer/ had suffered from skin cancer or show an early stage of skin cancer or have a genetic predisposition for skin cancer;
4. Other skin disease that requires treatment with other medications in the treatment area or in the distance of 3 cm;
5. Immunosuppression or current treatment for cancer;
6. Clinically unstable medical condition;
7. High risk group for HIV infection or presentation of other infectious diseases
8. Presentation of contact allergies or allergies to compounds of the test substances;
9. Smoker (more than forty cigarettes per day) or heavy drinker (more than three standard drinks per day);
10. Psychiatric disease that may interfere with follow up of study procedures;
11. Participation in other clinical trials up to 30 days prior to day 1 of the study
12. Prior treatment with study medication in the area to be treated;
13. Considered by the investigator, for any other reason, to be an unsuitable candidate for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eryfotona AK-NMSC® cream	Device: Eryfotona AK-NMSC® cream; Cream, to be applied according to COLIPA standard at 2 mg/cm² in head and neck, twice a day before exposing to sun light morning and around lunchtime (about 4-6 hours later), for up to 6 months.
Other: Sunscreen SPF 50+	Other: Sunscreen SPF 50+; Cream, to be applied according to COLIPA standard at 2 mg/cm² in head and neck, twice a day before exposing to sun light morning and around lunchtime (about 4-6 hours later), for up to 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with partial clearance of AK lesions	Comparison between treatment groups at the end of the treatment period	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with clearance and improvement of AK lesions	Comparison between treatment groups at the end of the treatment period	6 months
Total number of AK lesions in the treated area (including all lesions present at baseline as well as subclinical lesions which appeared during therapy)	Comparison between treatment groups at the end of the treatment period	6 months
Percentage of patients with improvement (clinical and dermoscopic assessment) of the target area as for the erythema, scaling, pigmentation and follicular plugs	Comparison between treatment groups at the end of the treatment period	6 months
Percentage of patients with changes in the Investigator Global Improvement Index	Comparison between treatment groups at the end of the treatment period	6 months
Percentage of patients with changes in Baseline Severity Index (BSI)	Comparison between treatment groups at the end of the treatment period	6 months
Percentage of patients with improvement in the target AK lesion by using RCM score.	Comparison between treatment groups at the end of the treatment period	6 months
Percentage of patients with improvement in the "cancerization filed" by RCM score	Comparison between treatment groups at the end of the treatment period Validation of a new RCM score	6 months
Percentage of patients compliant to treatment	Comparison between treatment groups at the end of the treatment period	6 months
Percentage of patients which report satisfaction to local tolerability	Comparison between treatment groups over time and at the end of the treatment period	6 months
Number of patients with AEs and local AEs (skin reactions)	Comparison between treatment groups over time and at the end of the treatment period	6 months
Percentage of patients which report satisfaction to treatment	Comparison between treatment groups at the end of the treatment period	6 months

Collaborators and Investigators

• Sponsor: ISDIN
• Investigators: Principal Investigator: Dr. Giuseppe Argenziano,, MD, PhD, Dermatology Unit, Medical Department /Arcispedale Santa Maria Nuova /Reggio Emilia, Italy

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): January 1, 2014
• Study Completion (Anticipated): January 1, 2014

Study Registration Dates

• First Submitted: July 24, 2012
• First Submitted That Met QC Criteria: August 1, 2012
• First Posted (Estimate): August 2, 2012

Study Record Updates

• Last Update Posted (Estimate): October 11, 2013
• Last Update Submitted That Met QC Criteria: October 10, 2013
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Actinic Keratosis; AK
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Physiological Effects of Drugs; Protective Agents; Dermatologic Agents; Radiation-Protective Agents; Sunscreening Agents
• Other Study ID Numbers: ISD-FPT-01-2012